Treatment Algorithms

Key Findings from Treatment Algorithms: Bipolar Disorder

Introduction:

Bipolar disorder (BPD) is a chronic illness characterized by recurrent episodes of aberrant mood. Treatment must be tailored to each patient’s current disease stage (i.e., acute manic episode, acute depressive episode, and maintenance phase). Historically, mood stabilizers such as lithium and antiepileptic drugs (AEDs) were the mainstay of treatment, but in recent years, atypical antipsychotics have played a larger role following their regulatory approval for bipolar depression and bipolar mania and as maintenance therapies. Use of antidepressants continues to occupy a large place in the BPD treatment algorithm, despite the lack of consistent evidence of their efficacy in this patient population. Preferred agents include the AED lamotrigine (GlaxoSmithKline’s Lamictal, generics), whose patient share in BPD has remained steady over the past five quarters of our analysis. Physicians perceive lamotrigine as an effective prophylaxis for bipolar depression and one of the safest therapies among the mood stabilizers and antipsychotics used for BPD, despite the risk of a rare, life-threatening rash.

Within the atypical antipsychotic drug class, Bristol-Myers Squibb/Otsuka’s Abilify (aripiprazole) and quetiapine (AstraZeneca’s Seroquel, generics) continue to play the large roles in BPD treatment; among newly diagnosed patients, Abilify and quetiapine are virtually tied for first-line patient share. Thought leaders consider Abilify and ziprasidone (Pfizer’s Geodon, generics) as having a lower propensity to cause weight gain and metabolic side effects compared with quetiapine and olanzapine (Eli Lilly’s Zyprexa, generics) but also as being less effective than quetiapine and olanzapine for certain phases of treatment. Quetiapine’s approval for treatment of both poles of BPD—mania and depression—sets this agent apart from other atypical antipsychotics and has helped make it a key market leader in this drug class. Newly emerging agents, more specifically, those in the atypical antipsychotic drug class, will compete in a crowded and genericized market. It is not enough for emerging agents to offer a better weight-gain profile over current agents; they must also demonstrate efficacy for more than just the treatment of mania to make an impact on the market. Using patient-level claims data, this report determines the share of each currently marketed drug by line of therapy, evaluates therapy flow, and analyzes why key drugs are chosen over others.

Questions Answered in This Report:

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Newly diagnosed patients: Treatment of BPD is dictated by the phase of the illness that the patient is experiencing: acute manic episode, acute depressive episode, or long-term maintenance. Typically, newly diagnosed patients are experiencing a depressive episode when they present to a healthcare provider; not surprisingly, then, therapies that physicians prefer for bipolar depression dominate early-line therapy. What drugs and drug classes compete for first-line patient share in newly diagnosed BPD patients? What are the dynamics of branded agents, such as Seroquel XR (AstraZeneca), Cymbalta (Eli Lilly’s duloxetine), and Abilify (Bristol-Myers Squibb/Otsuka), across early lines of therapy?

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Recently treated patients: AEDs and selective serotonin reuptake inhibitors (SSRIs) are generally considered safer and more tolerable than atypical antipsychotics, but because of antipsychotics’ relatively greater efficacy in treating BPD symptoms such as mania, antipsychotics are often added to existing treatment regimens in later lines. Lamotrigine (GlaxoSmithKline’s Lamictal, generics), quetiapine (AstraZeneca’s Seroquel, generics), and Abilify are among the most commonly used antipsychotics for BPD, according to our recently treated patient analysis. How do the pathways to each drug in BPD differ? How do the differentiating features of each branded drug influence the progression to that drug within the key analysis period? How long does it take a patient to move through preceding therapy before he or she adds quetiapine or Abilify?

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Pathways to key therapies: Longitudinal claims data reveal that lamotrigine is the leading agent in first-, second-, and third-line therapy for BPD; these data also detail which agents in a given class compete with lamotrigine. Which drugs precede the use of lamotrigine? Which drugs are used most often in combination with lamotrigine? How much is Abilify competing with quetiapine for second- and third-line space? Which drug(s) precede the use of Latuda (Dainippon Sumitomo Pharma/Sunovion/Takeda Pharmaceuticals’ lurasidone), one of the up-and-coming therapies in the BPD space, following its U.S. approval for bipolar depression?

Scope:

Primary patient-level data: Quantitative findings from our analysis of data covering approximately 40 million lives providing the most representative sample of U.S. treatment practice for Medicare and commercially insured patients. This report is delivered as a key findings slide deck and a dashboard that can be accessed using the Internet with claims that are less than six months old at the time of publication.

Patient Sample:

Patients aged 18 or older who are continuously enrolled for the complete two-year study period must meet the following condition: at least one claim with a diagnosis code for BPD (International Classification of Diseases, Ninth Revision [ICD-9] diagnostic codes (296.0, 296.1, 296.4, 296.5, 296.6, 296.7, 296.80, and 296.89) during the study period.

Quantified lines of therapy analysis showing exact share of each agent in each line of therapy, including rate of progression between lines and length of time patients are on each line.

Newly Diagnosed Patients:

- Patient share by drug class and key products across three lines of therapy, within one year of diagnosis.

- Patient flowchart through one year of treatment for all first-line products, including progression rates and add/switch behavior.